Mgr, Quality Ops, Engineering, Assurance
Hayward, CA 
Share
Posted 17 days ago
Job Description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Your Role at Baxter

Day-to-day activities of the Quality Operations, Inspections/Release, and Quality Engineering. This person will handle cGMP compliance and Inspection readiness by ensuring quality and compliance are built into day-to-day operations.

What you'll be doing

  • Implementation and improvement of Quality Processes that will assure compliance with Regulations, Corporate and Local procedures, and specifications.

  • Quality Representative in the manufacturing areas.

  • Manage the batch review and release activities.

  • Interfaces with regulators during regulatory inspections/ audits.

  • Identifies and manages continuous Improvement and VIP projects with the objective of achieving quality, reliability, and cost Improvements.

  • Ensure adherence to budget.

  • Support change control activities for manufacturing operations.

  • Manage the release process, inspection, and batch release activities.

  • Oversee, initiate, investigate and approve non-conformance report activities as needed.

  • Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.

  • Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements.

  • Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.

  • Interacts frequently with all levels of internal management as well as across functions and franchises.

  • Manages overall coaching, training, development and succession plans for the team.

What you'll bring

  • BS in science or engineering. 5+ years' experience in Quality, Manufacturing, Engineering or related field which should include 1-2 years of supervisory experience in a Medical Device or Pharma Industry.

  • Good working knowledge of applicable quality and regulatory standards and regulations

  • Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

  • Thorough knowledge of applicable procedures, specifications, regulations, and standards.

  • Strong leadership skills and demonstrated success in managing mid to large teams. Capable of managing in matrix and ability to interact successfully with multi-functions globally.

  • Strong analytical and problem-solving skills.

  • Good project management skills.

  • May perform other duties as assigned.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - $1143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

#LI-KV1

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

125545

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
5+ years
Email this Job to Yourself or a Friend
Indicates required fields